PT  - JOURNAL ARTICLE
AU  - Daniel J. Zuccarello
AU  - Michael P. Murphy
AU  - Richard F. Meyer
AU  - Paul A. Winslow
TI  - A Comprehensive Approach for the Determination of Extractable and Leachable Metals in Pharmaceutical Products by Inductively-Coupled Plasma
DP  - 2009 Jul 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 339--352
VI  - 63
IP  - 4
4099  - http://journal.pda.org/content/63/4/339.short
4100  - http://journal.pda.org/content/63/4/339.full
SO  - PDA J Pharm Sci Technol2009 Jul 01; 63
AB  - A comprehensive digestive approach for determining the extractable and leachable metals in pharmaceutical products by inductively-coupled plasma is investigated. This study examines several acid digestion strategies for packaging materials, containers, and formulated products for complete trace metals analysis. Packaging materials, a food product, and a simulated drug product are evaluated for leachable metals by stressing the materials under accelerated stability conditions. Trace metal profiles of 64 elements for these materials are reported.